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Atherosclerosis clinical trials

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NCT ID: NCT01469195 Not yet recruiting - Clinical trials for Coronary Artery Disease

A Lead Rectangle to Lower the Operator's Radiation Exposure

Start date: December 2011
Phase: N/A
Study type: Observational

During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Despite typical precautions (i.e., hanging a lead shield between the patient and the operator), many operators will be exposed to high radiation dose (higher than the permitted 50 miliS per year), this long term radiation exposure may result in stochastic and deterministic effects. The purpose of this study was to test the hypothesis that a non disposable radiation protection drape (that will cover the lower part of the patient) could help minimize the radiation scattered from the patient to the operator. In a procedure done through the Radial approach, there is a large portion of the patients (from the umbilicus and down) that is a source of scatter radiation to the operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of uniform thickness will be inserted into a sterile nylon bag and will be used during fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm respectively and was shown not to hinder the field of radiation needed for fluoroscopy and cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown not to interfere with the radiation field needed for angiography or angioplasty). The Investigators anticipate that the study will show a significant reduction in radiation exposure and hence reduce the radiation hazard to the operator.

NCT ID: NCT01353066 Not yet recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM)

EURDSS
Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at the control of CVRF in T2DM may not translate in the reduction of CV events. Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) could be superior in the control of the progression of subclinical atherosclerotic disease, as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9 kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients

NCT ID: NCT01344694 Not yet recruiting - Atherosclerosis Clinical Trials

Epicardial Fat, Visceral Fat and Coronary Atherosclerosis

Start date: July 2011
Phase: N/A
Study type: Observational

Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.

NCT ID: NCT01012583 Not yet recruiting - Atherosclerosis Clinical Trials

Optical Coherence TomOgraphy Assessment of the Drug-Eluting Stent

OCTOBER
Start date: November 2009
Phase: N/A
Study type: Observational

BACKGROUND Treatment of coronary atherosclerotic disease has been significantly advanced by interventional cardiology, and the advent of coronary arterial stents. In comparison to angioplasty alone, stents have reduced the incidence of angiographic as well as clinical restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG) surgery, repeat revascularization and the occurrence of major adverse cardiac events (MACE).However the long-term success of this therapy has been limited by the occurrence of in-stent restenosis. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter, as compared to angioplasty alone, in-stent restenosis occurs within 6 to 9 months after stent placement in 15% to 35% of patients. While stents can reduce restenosis by blocking vascular recoil and remodeling, mechanical intervention alone has been incapable of treating this biological problem of neointimal hyperplasia, particularly in the subset of patients with diabetes, long lesions or small vessel disease.Drug-eluting stents (DES) were developed as a viable method for focused delivery of anti-restenosis compounds to target lesions for the reduction of restenosis. Of the DES available and with the results of up to six (6) years clinical follow-up, the sirolimus-eluting stent (SES) has become the current gold standard for stent implantation. With the advent of using DES to treat complex lesions such as longer lesions requiring the use of multiple stents and the use in bifurcation lesions, the risk of stent thrombosis has increase.Late stent thrombosis has also been reported following DES implantation.Long term treatment with dual anti-platelet therapy following stent implantation has become the solution used to counteract the risk of stent thrombosis, this solution does not come without it's own risks and is an expensive therapy. Another specific problem of DES is delayed endothelization, and this may be and attributing factor in prolonging the period of thrombotic risk as shown by pathological findings at autopsy following SES implantation. These examinations have shown that even after 16 months, neointimal healing is still incomplete with approximately 20% of stent struts being found uncovered. Questions have arose that the problems of late thrombosis and delayed endothelization of stent struts with DES could be the result of the permanent polymer that is used as the bonding agent for the anti-restenosis compounds to the stents.Intravascular Ultrasound (IVUS) along with angiography has been the techniques used to gain data on DES to this point. Angiography is a 2 dimensional tool that gives a view of the vessel and IVUS gives a more 3 dimensional view of the vessel. IVUS does have its limitations, as stent struts are reflectors of sonic waves, shadowing around and behind the struts occurs. IVUS is also limited in detecting malapposition of the struts to the vessel wall especially if the area between the vessel wall and the strut in very small. RATIONALE Optical Coherence Tomography (OCT) is an optical analogue of IVUS that uses an infrared light source and measures the backscatter of the light. With this technique a higher level of resolution compared with IVUS has been reported.OCT has been reported as being able to visualize and detect atherosclerotic plaques and assess more accurately strut malapposition and the presence or thickness of neointimal hyperplasia as compared to IVUS. With the question of delayed endothelization due to the permanent polymer being a probable risk for late stent thrombosis, it is felt that OCT post stent implantation may give a more accurate assessment of stent strut endothelial coverage. This study is designed to compare the intimal hyperplasia following implantation of the Excel DES with a biodegradable polymer vs. the Cypher DES with a permanent polymer using OCT.

NCT ID: NCT00750789 Not yet recruiting - Atherosclerosis Clinical Trials

The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults

Start date: September 2008
Phase: Phase 4
Study type: Interventional

It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.

NCT ID: NCT00742352 Not yet recruiting - Atherosclerosis Clinical Trials

PET FDG Assessment of Change in Atherosclerotic Plaques After Chemotherapy

Start date: September 2008
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether chemotherapy induces regression in atherosclerotic plaques in oncologic patients already undergoing PET FDG as part of their routine assessment.We will use PET FDG to assess whether the inflammation in atherosclerotic plaques is affected by chemotherapy and anti angiogenic therapy.

NCT ID: NCT00732407 Not yet recruiting - Diabetes Mellitus Clinical Trials

Aliskiren's Effect on Arterial Stiffness and Platelet Function in Patients With Diabetes Mellitus (DM)

Start date: September 2008
Phase: N/A
Study type: Interventional

Aliskiren is a novel renin inhibitor approved for the treatment of hypertension. The effect of aliskiren on arterial stiffness, inflammation and oxidative stress has not been fully investigated yet.The aim of this study is to investigate the effect of aliskiren on arterial stiffness, platelet function and inflammation compared to losatan in patients with diabetes mellitus. We hypothesize that aliskiren will have a beneficial effect on arterial stiffness and platelet function in patients with diabetes mellitus.

NCT ID: NCT00484965 Not yet recruiting - Atherosclerosis Clinical Trials

Erythrocyte-Mediated Drug Delivery for the Prevention of Stent Restenosis

TROY
Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether erythrocyte mediated dexamethasone delivery reduces circulating inflammatory markers after coronary stent implantation and improves clinical and angiographic outcomes.

NCT ID: NCT00470808 Not yet recruiting - Atherosclerosis Clinical Trials

The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

POMX
Start date: May 2007
Phase: Phase 4
Study type: Interventional

Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.

NCT ID: NCT00388869 Not yet recruiting - Hypertension Clinical Trials

Renal Artery Calcium and Hypertension

Start date: November 2006
Phase: N/A
Study type: Observational

CT of the abdomen is a very common examination performed for various indications.One of the common findings is vascular calcifications including calcifications of the renal arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of this condition is imperative. The goal of our study is to investigate the correlation between incidental calcifications of the renal arteries in CT examinations and the presence of actual stenosis of these vessels in patients with and without hypertension.